Bill Mixon, RPh, MS Senior Associate

Gates Healthcare Associates

14 pharmacists and 1 epidemiologist make up the committee

USP staff

FDA and CDC representatives have input but do not vote

Call for Candidates for the 2015-2020 cycle ◦ Deadline for membership applications to the Expert Committee

◦ Members are elected in June and begin their work July 1st.

◦ Face to face meetings typically occur twice a year at the USP Headquarters in Rockville, MD

PF is an online journal in which USP publishes revisions to USP–NF for public review and comment.

◦ Free, online-only resource

◦ Published every 2 months

◦ One-time registration is required to access PF

www.usp.org/usp-nf/pharmacopeial-forum

General Chapter <800> is posted online at https://www.usp.org/usp-nf/notices/compounding-notice

◦ Submit comments with corresponding line numbers

◦ Email comments to CompoundingSL@usp.org

◦ Comments due July 31st, 2014

Chapter 800 adds to compounding standards by: ◦ Incorporating information contained in USP <795> and <797> and

builds on it

◦ Clearly makes OSHA standards a priority

◦ Is written to protect the health care worker and the environment we work in

◦ Adds the element of containment of Hazardous Drugs

◦ The philosophy of the chapter is THERE IS NO ACCEPTABLE LEVEL OF EXPOSURE TO HAZARDOUS DRUGS

◦ Exposure should be limited to the lowest possible level by using engineering controls and personal protective equipment

• NIOSH ALERT: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings

• ASHP Guidelines on Handling Hazardous Drugs

• Workplace Solutions: Personal Protective Equipment for Health Care Workers (CDC)

• Oncology Nursing Society: Safe Handling of Hazardous Drugs

List of Hazardous Drugs

Types of Exposure

Responsibilities of Personnel Handling Hazardous Drugs

Facility Design and Engineering Controls

Personal Protective Equipment

Hazard Communication Program

Training for Compounding Personnel

Receiving

Transporting

Dispensing HD Dosage Forms Not

Requiring Alteration

Compounding HD Dosage Forms

Protection When Administering HDs

Cleaning: Deactivation,

Decontamination, Cleaning, and

Disinfection

Spill Control

Disposal

Environmental Quality and Control

Documentation

Medical Surveillance

Protect personnel and the environment

Includes, but not limited to receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing, and otherwise altering, counting, crushing, or pouring HDs

Includes both non-sterile and sterile products and preparations

Standards apply to all personnel who compound HDs preparations and all places where HDs are prepared, stored, transported, and administered

A comprehensive approach to prevent worker and environmental exposure ◦ Engineering controls (including primary, secondary and supplemental)

◦ Compounding Supervisor who is knowledgeable about the standards

◦ Competent personnel

◦ Robust work practices

◦ Availability of appropriate Personal Protective Equipment (PPE)

◦ Medical surveillance program

Designated individual

Develops and implements appropriate procedures

Oversees facility compliance with this chapter and other applicable laws, regulations, and standards

Ensures competency of personnel

Assures environmental control of the compounding areas

Must be knowledgeable about the standards

Any drug identified by at least one of the following six criteria: ◦ Carcinogenicity ◦ Teratogenicity or developmental toxicity ◦ Reproductive toxicity in humans ◦ Organ toxicity at low doses in humans or animals ◦ Genotoxicity ◦ New drugs that mimic existing hazardous drugs in

structure or toxicity

• Not all drugs on the NIOSH list are cytotoxic agents

• Some dosage forms defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation (coated tablets, capsules)

• What about uncoated tablet forms of NIOSH Listed drugs?

HDs shall not be stored, unpacked, compounded or otherwise manipulated in an area that is positive pressure relative to the surrounding areas

A laminar air flow workbench (LAFW) or compounding aseptic isolator (i.e. glove box) shall not be used for the compounding of a HD

HD’s must be received, unpacked and stored in a designated receiving area that has restricted access.

“HDs should be received from the supplier sealed in impervious plastic to segregate them from other drugs, to allow for safety in the receiving and internal transfer process, and should be immediately delivered to the C-SEC”.

Storage of antineoplastic HDs shall be separate from storage

of non-HDs

Requires a separate Refrigerator in negative pressure room

Storage of non-antineoplastic HDs shall be separate from

storage of non-HDs, unless only coated, final-manufactured

dosage forms are clearly labeled as HDs and safety strategies

are included in the entity’s policies and procedures.

Containment Primary Engineering

Control (C-PEC) ◦ Externally vented

Containment Secondary Engineering

Control ◦ Separate room ◦ Externally vented ◦ Negative pressure ◦ Appropriate air changes per hour

Containment Ventilated Enclosure (CVE)

Class I Biological Safety Cabinet (BSC)

Class II BSCs or Compounding Aseptic Containment

Isolators (CACIs) may be used for non-sterile compounding

if they are dedicated for non-sterile compounding

◦ If they are used for occasional non-sterile compounding, Class II BSCs or CACIs must undergo thorough cleaning and disinfection before being using for sterile compounding

A C-PEC is not required if manipulations are limited to handling of

intact final manufactured products (e.g. coated tablets or capsules)

that do not produce aerosols or gasses or involve manipulation of

powders

A C-PEC for non-sterile compounding can be placed in a room that

does not need to be ISO 7 nor have HEPA-filtered air

Negative

C-PEC

Class II Biological Safety Cabinet

Compounding Aseptic Containment Isolator - (CACI)

Elimination of the current allowance in <797> for facilities

that prepare a low volume of hazardous drugs that

permits placement of a Biological Safety Cabinet (BSC) or

Compounding Aseptic Containment Isolator (CACI) in a

non-negative pressure room

All hazardous drug compounding shall be done in a

separate area designated for hazardous drug

compounding

USP <797> currently does not allow a Segregated

Compounding Area for HDs

Containment Segregated Compounding Area

Low- and medium-risk CSPs

C-PEC in a separate negative pressure room

At least 12 air changes per hour

Maximum beyond-use time of 12 hours

Function C-PEC C-SEC ACPH (Airflow) BUD

Compounding sterile HD in a cleanroom

BSC or CACI ISO 7 Cleanroom 30 ACPH HEPA filtered

Per <797>

Compounding sterile HD in a CACI that meets the requirements listed in <797>

CACI C-SCA 12 ACPH exhausted outside

Per <797>

Compounding low- or medium- risk sterile HDs in a BSC

BSC C-SCA 12 ACPH exhausted outside

Per <797>

A C-PEC used for the preparation of HDs shall not be used for the

preparation of a non-HD unless the non-HD preparation is placed into

a protective outer wrapper before removal from the C-PEC and is

labeled to require PPE handling precautions.

“For entities that compound both non-sterile and sterile HDs, the

respective Containment Primary Engineering Controls (C-PEC)

shall be placed in segregated rooms separate from each other,

unless those C-PECs used for non-sterile compounding are

sufficiently effective that the room can continuously maintain ISO

7 classification throughout the non-sterile compounding activity”.

Non-Hazardous Compounds packaged & must be labeled as

Hazardous

• Closed System Drug-Transfer Devices

(CSTDs)

• CSTDs should be used when

compounding HDs when the dosage form

allows

• CSTDs shall be used when administering

HDs when the dosage form allows

• Gloves ASTM-tested chemotherapy

gloves Sterile gloves for sterile HD CSPs

• Gowns (Impervious)

• Head, hair, and sleeve covers

• Eye and face protection

• Respiratory protection

• Hazard Communication Program

• For All personnel who handle HDs

• Requirements for compounding personnel in

<795> and <797>

HDs in unit-dose or unit-of-use packaging that do not require any

further alteration before delivery to the patient or the patient’s

caregiver may be dispensed without any further requirements for

containment unless required by the manufacturer.

If the entity’s SOPs permit, non-antineoplastic HDs that require only

transfer from the manufacturer’s package to a prescription

container may be dispensed without any further requirements for

containment unless required by the manufacturer

Counting of HDs should be done carefully, and clean equipment

should be dedicated for use with these drugs

Compounding with HD’s requires primary and secondary engineering controls as described in the chapter.

Deactivation: Chemical process that renders chemical harmless

Decontamination: Reduces microbial burden

Cleaning HD areas includes Deactivation, Decontamination, & Disinfection

Personnel performing cleaning activities (including compounding, direct care, environmental services, laundry, waste handling, and others) shall be protected from inadvertent exposure to HDs. ◦ 2 pr ASTM tested chemo gloves ◦ Eye protection ◦ Face shields if there is a splash hazard ◦ Other PPE as required

Spills shall be contained and cleaned immediately by trained workers.

Signs shall be available to restrict access to the spill area.

Only trained workers with appropriate PPE shall manage an HD spill.

All workers who may be required to clean up a spill of HDs shall receive proper training in spill management and in the use of PPE and NIOSH901 certified respirators (see 6. Personal Protective Equipment).

Policies and procedures shall be developed to prevent spills and to govern clean-up of HD spills.

Written procedures shall specify who is responsible for spill management and shall address the size and scope of the spill.

Environmental quality and control

Documentation

Medical surveillance

General Chapter <800> is posted online at

https://www.usp.org/usp-nf/notices/compounding-notice

Submit comments with corresponding line numbers to

CompoundingSL@usp.org

Comments due July 31st, 2014